ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Trademarks of the GSK Group of Companies.

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol DISKUS® Inhaler Combination Product 250/50mcg Twice Daily With Salmeterol DISKUS® Inhaler 50mcg Twice Daily on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144911
• Other study ID #: SCO40043
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2005
• Last updated: October 26, 2016
• Start date: October 2004
• Est. completion date: December 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the FDA for use in patients with COPD.

Description:

A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS® inhaler Combination Product 250/50mcg twice daily (BID) with Salmeterol DISKUS® inhaler 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of COPD (chronic obstructive pulmonary disease).

• Current or previous cigarette smokers with a smoking history of at least 10 pack-years.

• History of a least 1 COPD exacerbation in the 12 months prior to screening.

• Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Exclusion Criteria:

• Current diagnosis of asthma.

• Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).

• Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.

• Lung resection surgery within 1 year of screening.

• Abnormal and clinically significant ECG findings at screening.

• Other inclusion and exclusion criteria will be evaluated at the first study visit.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Salmeterol

• Fluticasone Propionate/Salmeterol Combination Product

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Cowansville	Quebec
Canada	GSK Investigational Site	Grimsby	Ontario
Canada	GSK Investigational Site	La Malbaie	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Saint Leonard	Quebec
Canada	GSK Investigational Site	Sainte Jerome	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Sorel	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Winnipeg	Manitoba
United States	GSK Investigational Site	Abingdon	Virginia
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Auburn	Maine
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Champaign	Illinois
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Cherry Hill	New Jersey
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Coeur D'Alene	Idaho
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Corona	California
United States	GSK Investigational Site	Corsicana	Texas
United States	GSK Investigational Site	Cumberland	Rhode Island
United States	GSK Investigational Site	Deland	Florida
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Des Moines	Iowa
United States	GSK Investigational Site	Elizabeth City	North Carolina
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Gig Harbor	Washington
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Johnson City	Tennessee
United States	GSK Investigational Site	Kalamazoo	Michigan
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Larchmont	New York
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Lewistown	New York
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Morgantown	West Virginia
United States	GSK Investigational Site	Newport News	Virginia
United States	GSK Investigational Site	North Miami Beach	Florida
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Palmdale	California
United States	GSK Investigational Site	Paramount	California
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Peoria	Illinois
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rancho Mirage	California
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Sepulveda	California
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	Slidell	Louisiana
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	St. Charles	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Statesville	North Carolina
United States	GSK Investigational Site	Stockton	California
United States	GSK Investigational Site	Summit	New Jersey
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir Med. 2008 Aug;102(8):1099-108. doi: 10.1016/j.rmed.2008.04.019. Epub 2008 Jul 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of moderate/severe exacerbations over a 52 week treatment period.
Secondary	The time until the first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year.

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.